Clinical Trials Directory

Trials / Completed

CompletedNCT00169442

Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants

Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
745 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
10 Months – 18 Months
Healthy volunteers
Accepted

Summary

To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.

Detailed description

* Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age. * Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster. * Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.

Conditions

Interventions

TypeNameDescription
BIOLOGICALTritanrix™-HepB/Hiberix™ Kft.GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.
BIOLOGICALTritanrix™-HepB/Hiberix™GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine
BIOLOGICALHiberix™GSK Biologicals' Haemophilus influenzae type b vaccine
BIOLOGICALPolyribosil-Ribitol-Phosphate (PRP) vaccineplain PRP polysaccharide vaccine
BIOLOGICALTritanrix™-HepB KftGSK Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.

Timeline

Start date
2005-02-10
Primary completion
2006-03-01
Completion
2006-03-10
First posted
2005-09-15
Last updated
2018-06-06
Results posted
2017-02-28

Locations

3 sites across 1 country: Philippines

Source: ClinicalTrials.gov record NCT00169442. Inclusion in this directory is not an endorsement.